BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHENA 24GX0.75IN STRAIGHT BC

    MDR report key: 8362224 · Received February 22, 2019

    Report

    Report Number
    8041187-2019-00165
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    February 8, 2019
    Report Date
    April 12, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903868070
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 2 PHOTOS WERE RECEIVED FOR INVESTIGATION. IT WAS OBSERVED THAT THE ADAPTER HAD BEEN REMOVED, HOWEVER THE TIP SHIELD IS REMAINED IN THE HUB. 1 ACTUAL SAMPLE WITHOUT COVER AND ADAPTER WAS RECEIVED. THE SAMPLE WAS NOT DECONTAMINATED. SAFETY ACTIVATION FAILURE WAS OBSERVED. THE ADAPTER HAD BEEN REMOVED BUT THE TIP SHIELD IS REMAINED IN THE HUB. ACTUAL SAMPLE THE PHOTOS AND ACTUAL SAMPLE RECEIVED SHOW THE REPORTED NON-CONFORMANCE. THE COMPLAINT IS CONFIRMED AND PRODUCT IS OUT OF SPECIFICATION. THE SAMPLE WAS RETURNED WITHOUT COVER AND ADAPTER. NO ABNORMALLY WAS OBSERVED ON THE TIP SHIELD, V-CLIP AND CANNULA. THE PROBABLE ROOT CAUSE COULD BE DUE THE DAMAGED ADAPTER. HOWEVER, THE ROOT CAUSE COULD NOT BE CONFIRMED AS THE ADAPTER WAS NOT RETURNED FOR INVESTIGATION. CPM FOR MONTH OF FEB2019 BREACHED THE ACTION LIMIT, CAPA 821876 HAS BEEN RAISED TO ADDRESS SAFETY ACTIVATION FAILURE ISSUE AS THE RISK IS HIGH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER SUCCESSFUL PLACEMENT OF THE IV, THE CATHENA 24GX0.75IN STRAIGHT BC NEEDLE "CAME OUT UNSHIELDED" WHEN WITHDRAWN.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AFTER SUCCESSFUL PLACEMENT OF THE IV, THE CATHENA 24GX0.75IN STRAIGHT BC NEEDLE "CAME OUT UNSHIELDED" WHEN WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157574 CATHENA 24GX0.75IN STRAIGHT BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8116290 00382903868070

    Patients

    Seq Age Sex Outcome Treatment
    1 Other